Study in Children to Evaluate Non-Inferiority and Persistence up to 5 Years of GSK Bio Meningococcal Vaccine 134612

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This study has 2 phases, a vaccination phase and a long-term follow-up phase. In the vaccination phase of this study, the new meningococcal vaccine 134612 will be evaluated in children using Mencevax™ ACWY (in children above 2 years) or Meningitec™ (in children below 2 years) as controls. In the long-term follow-up phase of the study, the long-term protection offered by the vaccines will be assessed up to 5 years after vaccination.

Subjects will be randomized in the primary vaccination phase of the study; no new subjects will be enrolled during the long-term follow-up phase of the study.

Subjects will be enrolled in 3 age strata. Subjects including and above two years of age will receive either GSK Biologicals meningococcal vaccine 134612 or Mencevax™ ACWY, subjects below two years of age will receive either GSK Biologicals meningococcal vaccine 134612 or Meningitec™. All subjects will have 7 blood samples taken: prior and one month after vaccination and one, two, three, four and five years after vaccination.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.

Anti-tetanus toxoid seroprotection and antibody concentrations [ Time Frame: Prior to and one month after vaccination ]

Meningococcal hSBA titres in subjects below two years of age [ Time Frame: Prior to and one month after vaccination and 1, 2, 3, 4, and 5 years after vaccination ]

Occurrence of solicited local and general symptoms [ Time Frame: During the 4-day follow-up period after vaccination ]

Occurrence of unsolicited symptoms [ Time Frame: Up to one month after vaccination ]

Occurrence of serious adverse events (including meningococcal diseases) [ Time Frame: Up to six months after vaccination ]

Occurrence of specific adverse events of rash, new onset of chronic illness(es) and conditions prompting emergency room visits and physician office visits not related to common illnesses and any events related to lack of vaccine efficacy [ Time Frame: Up to six months after vaccination ]

Occurrence of serious adverse events related to vaccination and any event related to lack of vaccine efficacy (i.e. meningococcal disease) [ Time Frame: From 6 months up to five years after vaccination ]

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Ages Eligible for Study:

1 Year to 10 Years (Child)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Subjects who the investigator believes that their parent or guardian can and will comply with the requirements of the protocol.

A male or female between, and including, 1 through 10 years of age at the time of vaccination.

Written informed consent obtained from the parent or guardian of the subject.

Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Previously completed routine childhood vaccinations to the best of his/her parents/guardians' knowledge.

Exclusion Criteria:

For the primary phase:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.

Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.

Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine(s).

Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W, and/or Y (for subjects below 6 years) or within the last five previous years (for subjects 6 years old or above).

Identifier: 108658
For additional information about this study please refer to the GSK Clinical Study Register. The results of this study is summarised with long term immunogenicity studies 108660 (year 1), 108661 (year 2), 108663 (year 3) and 108665 (year 4) on the GSK Cli